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Sign in to claim this brandKreatech Biotechnology B.V.
US
Last updated May 24, 2026
What Kreatech Biotechnology B.V. makes
Kreatech Biotechnology B.V. manufactures fluorescence in situ hybridization (FISH) probes designed for nucleic acid hybridization detection in vitro diagnostics. These probes are used to identify and analyze specific genetic sequences in tissue samples, aiding in diagnostic applications such as cytogenetic analysis and cancer diagnostics.
The company’s FISH probes are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Kreatech Biotechnology B.V. manufacture?
Kreatech Biotechnology B.V. specializes in nucleic acid hybridization detection in vitro diagnostics (IVDs), specifically fluorescence in situ hybridization (FISH) probes. These probes are used to detect and analyze specific genetic sequences in tissue samples, which is critical for applications like cytogenetic analysis and cancer diagnostics. The company’s focus is on this single category of diagnostic tools.
Where is Kreatech Biotechnology B.V. based, and how does that affect its regulatory standing?
Kreatech Biotechnology B.V. is based in the United States, which means its devices are subject to FDA regulations. The company’s FISH probes are classified as Class I medical devices under FDA guidelines, indicating they pose minimal risk and typically require less stringent premarket review. This classification aligns with their use as diagnostic tools for genetic analysis.
Are Kreatech’s devices listed in any regulatory registries, and why is this important?
Yes, Kreatech’s FISH probes are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is important because it provides a standardized way to track and identify medical devices throughout their lifecycle, ensuring transparency in the supply chain, regulatory compliance, and traceability for healthcare providers. Listing in the UDI system helps streamline reporting and monitoring of device performance and safety.
How are Kreatech’s FISH probes classified under FDA regulations, and what does that mean for their use?
Kreatech’s FISH probes are classified as Class I medical devices by the FDA. This classification is based on their intended use—diagnostic tools for detecting genetic abnormalities in tissue samples—which the FDA determines carries a low risk to patients. Class I devices generally undergo less rigorous premarket review but must still comply with FDA quality system regulations to ensure safety and effectiveness. This classification reflects the probes’ role as routine diagnostic aids rather than high-risk interventions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- leicabiosystems.com
- —
- —
- [email protected]
- Phone
- +(31)206919181
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 406381124
Catalogue (197)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Kreatech FISH probes | 06Q003B495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 17C006B495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 07Q004I550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 40V018V495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 23C002J495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 12Q002V550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 08Q002I550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | KI-20017B | FDA UDI | Class I | Active |
| Kreatech FISH probes | 11Q003I495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 09P004B550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 03Q001B550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | KI-20006G | FDA UDI | Class I | Active |
| Kreatech FISH probes | KI-40001 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 20Q003B550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 11Q001I495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 12Q003V495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 07P001C495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 01Q001B550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 13Q002J415 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 14Q001B550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 13Q001C550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 24C002N415 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 18Q004V550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 22Q002B550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 09Q003B495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 06Q005B550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 13Q002I495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | KI-20001G | FDA UDI | Class I | Active |
| Kreatech FISH probes | 13Q004I495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 02P005B495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 12C001J495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 06Q001A550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 03Q003B495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 11Q005I550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | KI-20011B | FDA UDI | Class I | Active |
| Kreatech FISH probes | 16Q002I495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | KI-20017G | FDA UDI | Class I | Active |
| Kreatech FISH probes | 11Q009V495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 18Q003V495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 09P005B550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | KI-20015B | FDA UDI | Class I | Active |
| Kreatech FISH probes | 20P001B495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 08C003V495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 06Q002B495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 40V033V495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 03Q004C550 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 08Q005B495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 11Q002I495 | FDA UDI | Class I | Active |
| Kreatech FISH probes | 04Q004C415 | FDA UDI | Class I | Active |
| Kreatech FISH probes | KI-40002 | FDA UDI | Class I | Active |
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